# FDA 483 - Surface Dynamics LLC - September 26, 2018

Source: https://www.keypedia.com/records/483/surface-dynamics-llc/07a5ca47-581c-4f4b-9bd4-330159962597

> FDA 483 for Surface Dynamics LLC on September 26, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Surface Dynamics LLC
- Inspection Date: 2018-09-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Surface Dynamics LLC in Cincinnati, OH, was inspected and cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for process parameter monitoring, process validation, complaint handling, equipment calibration, sampling methods, and statistical techniques for process control. These issues indicate a lack of robust controls over critical manufacturing processes and quality management.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/surface-dynamics-llc/e4dc0780-9935-491c-905c-ff386a0e1fea

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22